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Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis

NCT06978660

RecruitingN/A

Sponsor: Idoven 1903 S.L.

Conditions: Transthyretin Cardiac Amyloidosis

Countries: United States, France, Germany, Spain, United Kingdom

CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin cardiac amyloidosis (ATTR-CA). Thus, this study will assess Willem™ ability to distinguish between truly diagnosed ATTR-CA patients and confirmed non-ATTR-CA patients from ECG data.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Subjects ≥ 18 years old
* Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format

Exclusion Criteria:

* Patients with paced rhythm on the ECG.
Locations (8)
  • Evanston, Illinois, United States
  • Toulouse, France
  • Bonn, Germany
  • München, Germany
  • Palma de Mallorca, Balearic Islands, Spain
  • San Sebastián, Guipúzcoa, Spain
  • Huelva, Huelva, Spain
  • Glasgow, United Kingdom